E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10003553 |
E.1.2 | Term | Asthma |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To demonstrate a reduction in the use of systemic corticosteroids with fevipiprant, compared with placebo. |
Demostrar una reducción del uso de corticosteroides sistémicos con fevipiprant, comparado con placebo |
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E.2.2 | Secondary objectives of the trial |
1. To evaluate the effect of fevipiprant in terms of difference in daytime and night-time symptom scores using an electronic diary 2. To evaluate the effect of fevipiprant with respect to change from baseline in Asthma Control Questionnaire (ACQ-5) total score 3. To evaluate the effect of fevipiprant with respect to change from baseline in Asthma Related Quality of Life Questionnaire (AQLQ+12) total score 4. To evaluate the effect of fevipiprant in terms of proportion of patients requiring >=7.5mg systemic corticosteroid dose in mg per day continuously for at least 30 days 5. To evaluate the effect of fevipiprant in terms of proportion of patients with no systemic corticosteroid use 6. To evaluate the effect of fevipiprant in terms of time to first prescription of biologic therapy from first dose of study treatment received |
1. Evaluar el efecto de fevipiprant en términos de la diferencia en las puntuaciones de los síntomas diurnos y nocturnos usando un diario electrónico 2. Evaluar la eficacia de fevipiprant con respecto al cambio en la puntuación del cuestionario de control del asma (ACQ-5), respecto a la visita basal, en la población total. 3. Evaluar el efecto de fevipiprant con respecto al cambio en la puntuación del cuestionario de calidad de vida en pacientes con asma (AQLQ+12) en la población total. 4. Evaluar el efecto de fevipiprant en términos de proporción de pacientes que reciban dosis en mg de corticosteroides sistémicos ≥ 7.5 mg por día de forma continuada durante al menos 30 días 5. Evaluar el efecto de fevipiprant en términos de la proporción de pacientes que no utilicen corticosteroides sistémicos 6. Evaluar el efecto de fevipiprant en términos del tiempo hasta la primera prescripción de terapia biológica desde la primera dosis del tratamiento del estudio recibido. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Patients with a diagnosis of asthma for a period of at least 3 months prior to Screening Visit with current asthma severity step 4 or 5 (GINA 2018) -Currently on treatment with medium or high dose ICS/LABA +/- other controller (i.e.LAMA, LTRA etc. as per GINA) for a minimum of 6 weeks prior to Screening Visit -At screening, patients with FEV1 of <=80% of the predicted normal value for the patient, after withholding bronchodilators at Screening Visit and beginning of Run-In Visit . -An increase of >=12% and >=200 ml in FEV1 approximately 10 to 15 minutes after administration of 400 mcg of salbutamol/albuterol prior to randomization (documented historical reversibility is accepted). -Demonstration of inadequate control of asthma based on an ACQ-5 score >=1.5 at Screening Visit and Treatment Day 1 Visit -Documented history of at least 1 asthma exacerbation within 1 year prior to enrolment |
-Pacientes con un diagnóstico de asma durante un periodo de por lo menos 3 meses antes de la visita de selección con severidad del asma actual en escalón 4 ó 5 (GINA 2018). -Actualmente en tratamiento con dosis medias o altas de ICS/LABA +/- otro controlador (ej. LAMA, LTRA, etc según la guía GINA) durante un mínimo de 6 semanas antes de la visita de selección. -En la selección, pacientes con FEV1 de <= 80% del valor teórico normal para el paciente, después de suspender los broncodilatadores en la visita de selección y al inicio de la visita de inclusión. -Un aumento de >=12% y >=200 ml del FEV1 aproximadamente de 10 a 15 minutos después de la administración de 400 mcg of salbutamol/albuterol antes de la aleatorización (se acepta reversibilidad histórica documentada) - Demostración de control insuficiente del asma basado en una puntuación del ACQ-5 >=1.5 en la visita de selección y en la visita de aleatorización. - Antecedentes documentados de por lo menos 1 exacerbación del asma dentro del año previo a la inclusión. |
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E.4 | Principal exclusion criteria |
-Asthma exacerbation, within 6 weeks prior to enrolment (screening) that required SCS, hospitalization, or emergency room visit. -Chronic/ maintenance use of OCS for asthma ( total OCS use days greater than 6 months; continuously or intermittently) within the last year -Prior use of biologics that has potential to interfere/ affect asthma disease progression, in the previous 6 months from run-in period. -Any contra-indications of SCS use e.g. diabetes, narrow angle glaucoma, or any other as defined by the treating physician -Pregnant or nursing (lactating) women -Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer |
- Exacerbación del asma, dentro de las 6 semanas antes de la inclusión (selección) que precise SCS, hospitalización o visita a urgencias. - Uso crónico/mantenimiento de corticosteroides orales (SCS) para el asma (el uso regular de SCS durante más de 6 meses; de forma continua o intermitente) dentro del último año. - Uso previo de biológicos que posea el potencial de interferir/afectar la progresión del asma, en los 6 meses previos. - Cualquier contraindicación para el uso de SCS, por ejemplo, diabetes, glaucoma de ángulo cerrado o cualquier otra definida por el médico que trate al paciente - Mujeres embarazadas o en periodo de lactancia. - Uso de otros fármacos en investigación dentro de las 5 vidas medias del reclutamiento, o dentro de 30 días, lo que sea más largo |
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E.5 End points |
E.5.1 | Primary end point(s) |
Total systemic corticosteroid dose use |
Uso total de dosis de corticosteroides sistémicos |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Change from baseline in daytime and night-time symptoms using an electronic diary. The diary consists of 5 questions regarding daytime and nocturnal asthma symptom - Change from baseline in Asthma Control Questionnaire total score. The ACQ-5 consists of 5 questions on a 7-point scale (0=no impairment, 6=maximum impairment). - Change from baseline in Asthma Related Quality of Life Questionnaire total score. AQLQ+12 consists of 32 questions each scaled from 1 to 7, where 1 indicates maximal impairment and 7 indicates no impairment - Proportion of patients requiring ≥ 7.5mg systemic corticosteroid dose in mg per day continuously for at least 30 days - Proportion of patients with no systemic corticosteroid use - Time to first prescription of biologic therapy from first dose of study treatment received |
- Cambio desde la visita basal de los síntomas diurnos y nocturnos usando un diario electrónico. El diario consiste en 5 preguntas respect a los sintomas de asma diurnos y nocturnos. - Cambio desde la visita basal en la puntuación del cuestionario de control del asma. El ACQ-5 consiste en 5 preguntas en una escala de 7 puntos (0= no deterioro, 6= máximo deterioro). - Cambio desde la visita basal en la puntuación del cuestionario de calidad de vida en pacientes con asma (AQLQ+12). El AQLQ+12 consiste en 32 preguntas con unas escala de 1 a 7, donde 1 indica máximo deterioro y 7 indica no deterioro - Proporción de pacientes que requieren dosis de ≥ 7.5 mg de corticosteroides sistémicos por día de forma continuada durante al menos 30 días - Proporción de pacientes que no utilicen corticosteroides sistémicos - Tiempo hasta la primera prescripción de terapia biológica desde la primera dosis del tratamiento del estudio recibido. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 94 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Belgium |
Bulgaria |
Chile |
Colombia |
Costa Rica |
Czech Republic |
France |
Germany |
Greece |
Hungary |
Peru |
Philippines |
Russian Federation |
Slovakia |
South Africa |
Spain |
Thailand |
Turkey |
United Kingdom |
United States |
Vietnam |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS |
Última Visita del Último Sujeto |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 11 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 10 |